SILDENAFIL HEXAL sildenafil (as citrate) 50 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate, Quantity: 70.2 mg (Equivalent: sildenafil, Qty 50 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: indigo carmine aluminium lake; croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate; magnesium stearate; copovidone; saccharin sodium

Administration route:

Oral

Units in package:

4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SILDENAFIL HEXAL is indicated for the treatment of erectile dysfunction in adult males. SILDENAFIL HEXAL is not indicated for use by women.

Product summary:

Visual Identification: light blue round slightly dotted tablets, with cross breaking notch and debossment 50; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-11-23

Patient Information leaflet

SILDENAFIL HEXAL
1
SILDENAFIL HEXAL
_sildenafil citrate tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sildenafil Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
It should only be used under strict
medical supervision.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SILDENAFIL HEXAL
IS USED FOR
This medicine is used to treat erectile
dysfunction, more commonly known
as impotence in men. This is when a
man cannot get, or keep a hard erect
penis suitable for sexual activity.
It contains the active ingredient
sildenafil. Sildenafil belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
It works by relaxing the blood
vessels in your penis when you are
sexually excited. This allows blood
to flow into your penis, allowing you
to get an erection in the natural way.
Sildenafil Hexal will work only if
you are sexually excited. It will not
increase your sex drive.
Sildenafil Hexal is not for use in
women.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
SILDENAFIL HEXAL
YOU MUST NOT TAKE SILDENAFIL HEXAL
IF YOU ARE TAKING ANY NITRATES OR
NITRITE MEDICATIONS. IT MAY LEAD TO
A SEVERE DROP IN BLOOD PRESSURE,
WHICH MAY BE DIFFICULT TO TREAT.
BECAUSE SEXUAL ACTIVITY MAY PLACE A
STRAIN ON YOUR HEART, YOUR DOCTOR
WILL NEED TO CHECK WHETHER YOU ARE
FIT ENOUGH TO TAKE SILDENAFIL HEXAL.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
sildenafil, the active ingredient,
or to any of the other

Summary of Product characteristics

181116-Sildenafil Hexal-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
SILDENAFIL HEXAL (SILDENAFIL (AS CITRATE))
1.
NAME OF THE MEDICINE
Sildenafil (as citrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sildenafil Hexal 50 mg tablets contains 50 mg Sildenafil (as
citrate).
Sildenafil citrate is an off-white, crystalline powder. Its aqueous
solubility is equivalent to 2.6
mg sildenafil per millilitre at 25
°
C.
For the full list of excipients, see Section 6.1 List of excipients.
_Not all presentations may be marketed in Australia. _
3.
PHARMACEUTICAL FORM
Sildenafil Hexal 50 mg tablets: Light blue round slightly dotted
tablets with cross breaking
notch and embossment “50”.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sildenafil Hexal is indicated for the treatment of erectile
dysfunction in adult males.
Sildenafil Hexal is not indicated for use by women.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_USE IN ADULTS _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual
activity. Based on the efficacy and toleration, the dose may be
increased to 100 mg or decreased
to 25 mg. The maximum recommended dose is 100 mg. The maximum
recommended dosing
frequency is once per day.
_USE IN CHILDREN _
Sildenafil Hexal is not indicated for use in children.
METHOD OF ADMINISTRATION
Sildenafil Hexal tablets are for oral administration. Sildenafil Hexal
tablets have a breaking
notch and may be broken if necessary.
DOSAGE ADJUSTMENT IN:

renal impairment
The dosing recommendations for ‘Use in adults’ should be followed
for patients with mild to
moderate renal impairment (Cl
cr
= 30-80 mL/min).
181116-Sildenafil Hexal-pi
Page 2 of 16
Since sildenafil clearance is reduced in patients with severe renal
impairment, (Cl
cr
< 30
mL/min) a 25 mg starting dose should be considered. Based on efficacy
and toleration, the dose
may be increased to 50 mg and 100 mg.

hepatic impairment
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g. cirrhosis), a 25
mg